DIABETES THERAPY MANAGEMENT SYSTEM FOR RECOMMENDING ADJUSTMENTS TO AN INSULIN INFUSION DEVICE

• US 20130338630A1
• Filed: 06/05/2013
• Published: 12/19/2013
• Est. Priority Date: 06/07/2012
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Agrawal, Pratik, Kannard, Brian T., Kaufman, Francine R.
• Application Number:
  US13/910,773
• Publication Number:
  US 20130338630A1
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

A method of managing use of an insulin infusion device are provided. The method receives glucose data for a user of the infusion device, wherein the glucose data indicates blood glucose levels of the user for a period of time during which the insulin infusion device is regulating delivery of insulin to the user. The received glucose data is received to detect certain event occurrences, which may be indicative of a correctable basal rate setting of the insulin infusion device and/or indicative of potential maladjustment of a user-specific setting of a bolus calculator setting of the insulin infusion device. The method outputs a recommendation to adjust the basal rate setting and/or the bolus calculator setting as needed to address the detected event occurrences.

Claims

1. A method of managing use of an insulin infusion device, the method comprising:

receiving glucose data for a user of the insulin infusion device, the glucose data indicating blood glucose levels of the user for a specified period of time during which the insulin infusion device is regulating delivery of insulin to the user;

analyzing the received glucose data for presence of any of a plurality of event occurrences indicative of a correctable basal rate setting of the insulin infusion device;

detecting, in response to the analyzing, at least one of the plurality of event occurrences, resulting in one or more detected event occurrences; and

outputting a recommendation to adjust the basal rate setting of the insulin infusion device, wherein the recommendation is associated with the one or more detected event occurrences.

2. The method of claim 1, wherein the received glucose data indicates blood glucose levels of the user for the specified period of time over a plurality of days.

3. The method of claim 1, wherein the received glucose data comprises sensor glucose data obtained from a continuous glucose monitor sensor.

4. The method of claim 1, wherein the outputting comprises:

generating a report that includes the recommendation.

5. The method of claim 1, wherein:

the one or more detected event occurrences comprises a rate of change event that indicates an uncorrected increase in blood glucose level during the specified period of time; and

the recommendation comprises a suggestion to increase the basal rate setting for a time interval starting before a detected time interval of the rate of change event.

6. The method of claim 1, wherein:

the one or more detected event occurrences comprises a rate of change event that indicates an uncorrected decrease in blood glucose level during the specified period of time; and

the recommendation comprises a suggestion to decrease the basal rate setting for a time interval starting before a detected time interval of the rate of change event.

7. The method of claim 1, wherein:

the one or more detected event occurrences comprises an uncorrected persistent hypoglycemic event during the specified period of time; and

the recommendation comprises a suggestion to decrease the basal rate setting for a time interval starting before a detected time interval of the uncorrected persistent hypoglycemic event.

8. The method of claim 1, wherein:

the one or more detected event occurrences comprises an uncorrected persistent hyperglycemic event during the specified period of time; and

the recommendation comprises a suggestion to increase the basal rate setting for a time interval starting before a detected time interval of the uncorrected persistent hyperglycemic event.

9. The method of claim 1, wherein:

the one or more detected event occurrences comprises a high glucose variability event occurring at a designated time near a bolus event; and

the recommendation comprises a suggestion to adjust a bolus dosage for a meal bolus event that precedes the high glucose variability event.

10. The method of claim 1, further comprising:

filtering the received glucose data to remove glucose data associated with certain events during the specified period of time, resulting in filtered glucose data, wherein the analyzing step analyzes the filtered glucose data;

processing the removed glucose data associated with bolus delivery events;

detecting, in response to processing the removed glucose data, a correctable outcome for a bolus delivery event; and

outputting a bolus recommendation to adjust a bolus dosage corresponding to the bolus delivery event.

11. The method of claim 1, further comprising:

generating a command to initiate adjustment of the basal rate setting of the insulin infusion device in accordance with the recommendation.

12. A processor-based computer system comprising:

a device communications layer to receive glucose data for a user of an insulin infusion device, the glucose data indicating blood glucose levels of the user for a specified period of time during which the insulin infusion device is regulating delivery of insulin to the user;

a processor device to analyze the received glucose data for presence of any of a plurality of event occurrences indicative of a correctable basal rate setting of the insulin infusion device, and configured to detect, in response to the analyzing, at least one of the plurality of event occurrences, to determine one or more detected event occurrences; and

a reporting layer to output a recommendation to adjust the basal rate setting of the insulin infusion device, wherein the recommendation is associated with the one or more detected event occurrences.

13. The computer system of claim 12, wherein:

the one or more detected event occurrences comprises a rate of change event that indicates an uncorrected increase in blood glucose level during the specified period of time; and

the recommendation comprises a suggestion to increase the basal rate setting for a time interval starting before a detected time interval of the rate of change event.

14. The computer system of claim 12, wherein:

the one or more detected event occurrences comprises a rate of change event that indicates an uncorrected decrease in blood glucose level during the specified period of time; and

the recommendation comprises a suggestion to decrease the basal rate setting for a time interval starting before a detected time interval of the rate of change event.

15. The computer system of claim 12, wherein:

the one or more detected event occurrences comprises an uncorrected persistent hypoglycemic event during the specified period of time; and

the recommendation comprises a suggestion to decrease the basal rate setting for a time interval starting before a detected time interval of the uncorrected persistent hypoglycemic event.

16. The computer system of claim 12, wherein:

the one or more detected event occurrences comprises an uncorrected persistent hyperglycemic event during the specified period of time; and

the recommendation comprises a suggestion to increase the basal rate setting for a time interval starting before a detected time interval of the uncorrected persistent hyperglycemic event.

17. The computer system of claim 12, wherein:

the one or more detected event occurrences comprises a high glucose variability event occurring at a designated time near a bolus event; and

the recommendation comprises a suggestion to adjust a bolus dosage for a meal bolus event that precedes the high glucose variability event.

18. The computer system of claim 12, wherein the device communications layer is further configured to generate a command to initiate adjustment of the basal rate setting of the insulin infusion device in accordance with the recommendation.

19. A method of managing use of an insulin infusion device, the method comprising:

receiving glucose data for a user of the insulin infusion device, the glucose data indicating blood glucose levels of the user for a period of time during which the insulin infusion device is regulating delivery of insulin to the user;

reviewing the received glucose data to identify bolus calculator event data corresponding to use of a bolus calculator of the insulin infusion device, wherein the bolus calculator calculates each bolus dosage recommendation based on a respective user-entered carbohydrate consumption value, a respective user-entered current blood glucose value, and a user-specific bolus calculator setting;

analyzing the identified bolus calculator event data to detect one of a plurality of event occurrences indicative of potential maladjustment of the user-specific bolus calculator setting, resulting in a detected event occurrence; and

outputting a recommendation to adjust the user-specific bolus calculator setting of the insulin infusion device, wherein the recommendation is associated with the detected event occurrence.

20. The method of claim 19, wherein the received glucose data indicates blood glucose levels of the user for the period of time over a plurality of days.

21. The method of claim 19, wherein the received glucose data comprises sensor glucose data obtained from a continuous glucose monitor sensor.

22. The method of claim 19, further comprising:

filtering the identified bolus calculator event data to remove glucose data associated with an override of a bolus dosage recommendation, an active insulin condition, or a back-to-back bolus condition, resulting in filtered bolus calculator event data;

wherein the analyzing step analyzes the filtered bolus calculator event data.

23. The method of claim 19, further comprising:

filtering the identified bolus calculator event data to isolate correction bolus events having no food bolus component;

wherein;

the user-specific bolus calculator setting comprises an insulin sensitivity value for the user; and

the recommendation comprises a suggestion to adjust the insulin sensitivity value.

24. The method of claim 19, further comprising:

filtering the identified bolus calculator event data to isolate food bolus events having no correction bolus component;

wherein;

the user-specific bolus calculator setting comprises a carbohydrate ratio value for the user; and

the recommendation comprises a suggestion to adjust the carbohydrate ratio value.

25. The method of claim 19, wherein:

the detected event occurrence comprises a long term hypoglycemic event occurring after a food bolus event;

the user-specific bolus calculator setting comprises a carbohydrate ratio value for the user; and

the recommendation comprises a suggestion to increase the carbohydrate ratio value.

26. The method of claim 19, wherein:

the detected event occurrence comprises a long term hyperglycemic event occurring after a food bolus event;

the user-specific bolus calculator setting comprises a carbohydrate ratio value for the user; and

the recommendation comprises a suggestion to decrease the carbohydrate ratio value.

27. The method of claim 19, wherein:

the detected event occurrence comprises a limited increase or decrease in blood glucose level occurring at a designated time after a food bolus event;

the user-specific bolus calculator setting comprises a carbohydrate ratio value for the user; and

the recommendation comprises a suggestion to increase the carbohydrate ratio value.

28. The method of claim 19, wherein:

the detected event occurrence comprises a large increase in blood glucose level occurring at a designated time after a food bolus event;

the user-specific bolus calculator setting comprises a carbohydrate ratio value for the user; and

the recommendation comprises a suggestion to decrease the carbohydrate ratio value.

29. The method of claim 19, wherein:

the detected event occurrence comprises a high glucose variability event occurring after a food bolus event; and

the recommendation comprises a suggestion related to dietary habits of the user.

30. The method of claim 19, wherein:

the detected event occurrence comprises a long term hypoglycemic event occurring after a correction bolus event;

the user-specific bolus calculator setting comprises an insulin sensitivity value for the user; and

the recommendation comprises a suggestion to increase the insulin sensitivity value.

31. The method of claim 19, wherein:

the detected event occurrence comprises a long term hyperglycemic event occurring after a correction bolus event;

the user-specific bolus calculator setting comprises an insulin sensitivity value for the user; and

the recommendation comprises a suggestion to decrease the insulin sensitivity value.

32. The method of claim 19, wherein:

the detected event occurrence comprises a rapid decrease in blood glucose level occurring at a designated time after a correction bolus event;

the user-specific bolus calculator setting comprises an insulin sensitivity value for the user; and

the recommendation comprises a suggestion to increase the insulin sensitivity value.

33. The method of claim 19, wherein:

the detected event occurrence comprises a limited decrease or increase in blood glucose level occurring at a designated time after a correction bolus event;

the user-specific bolus calculator setting comprises an insulin sensitivity value for the user; and

the recommendation comprises a suggestion to decrease the insulin sensitivity value.

34. The method of claim 19, wherein:

the detected event occurrence comprises a long term high glucose variability event occurring after a food bolus event; and

the recommendation comprises a suggestion related to dietary habits of the user.

35. The method of claim 19, wherein:

the detected event occurrence comprises a high glucose variability event occurring at a designated time after a food bolus event; and

the recommendation comprises a suggestion related to dietary habits of the user.

36. The method of claim 19, wherein:

the detected event occurrence comprises a high negative rate of change event occurring at the food bolus event; and

the recommendation comprises a suggestion to consume a meal earlier, relative to a bolus infusion time.

37. The method of claim 19, wherein:

the detected event occurrence comprises a high positive rate of change event occurring at a food bolus event; and

the recommendation comprises a suggestion to consume a meal later, relative to a bolus infusion time.

38. The method of claim 19, wherein:

the detected event occurrence comprises a long term high glucose variability event occurring after a correction bolus event; and

the recommendation comprises a suggestion related to use of a glucose meter and a glucose sensor.

39. A processor-based computer system comprising:

a device communications layer configured to receive glucose data for a user of an insulin infusion device, the glucose data indicating blood glucose levels of the user for a period of time during which the insulin infusion device is regulating delivery of insulin to the user;

a processor device to;

review the received glucose data to identify bolus calculator event data corresponding to use of a bolus calculator of the insulin infusion device, wherein the bolus calculator calculates each bolus dosage recommendation based on a respective user-entered carbohydrate consumption value, a respective user-entered current blood glucose value, and a user-specific bolus calculator setting; and

analyze the identified bolus calculator event data to detect one of a plurality of event occurrences indicative of potential maladjustment of the user-specific bolus calculator setting, resulting in a detected event occurrence; and

a reporting layer to output a recommendation to adjust the user-specific bolus calculator setting of the insulin infusion device, wherein the recommendation is associated with the detected event occurrence.

40. The computer system of claim 39, wherein:

the processor device filters the identified bolus calculator event data to remove glucose data associated with an override of a bolus dosage recommendation, an active insulin condition, or a back-to-back bolus condition, resulting in filtered bolus calculator event data; and

the analyzing performed by the processor device analyzes the filtered bolus calculator event data.

41. The computer system of claim 39, wherein:

the processor device filters the identified bolus calculator event data to isolate correction bolus events having little to no food bolus component;

the user-specific bolus calculator setting comprises an insulin sensitivity value for the user; and

the recommendation comprises a suggestion to adjust the insulin sensitivity value.

42. The computer system of claim 39, wherein:

the processor device filters the identified bolus calculator event data to isolate food bolus events having little to no correction bolus component;

the user-specific bolus calculator setting comprises a carbohydrate ratio value for the user; and

the recommendation comprises a suggestion to adjust the carbohydrate ratio value.

43. The computer system of claim 39, wherein the device communications layer generates a command to initiate adjustment of the user-specific bolus calculator setting of the insulin infusion device in accordance with the recommendation.